Stavros KAKKOS, Associate Professor Department of Vascular Surgery, University of Patras Greece. Chairman: Ioannis Tsolakis
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1 Didactic Session 2: Challenging Problems in Chronic Venous Disease Efficacy of venoactive drugs in the management of symptoms and signs of chronic venous disease Stavros KAKKOS, Associate Professor Department of Vascular Surgery, University of Patras Greece. Chairman: Ioannis Tsolakis
2 Conflicts of interest Servier Pierre Fabre
3 Pain or aching Throbbing Tightness Heaviness Fatigue Feeling of swelling Cramps Itching Restless legs Paresthesia (tingling) Heat or burning sensation Venous symptoms SYM Vein consensus, 2016
4 Main categories of venoactive drugs IUA CVD consensus, 2018
5 Assessment of efficacy Consistent evidence from at least two RCTs is required to award a high level of evidence for each symptom or sign measure. The original trials might have been underpowered for some efficacy measures or individual symptoms.
6 Outcome measures Venous symptoms as described in the SYM Vein Consensus statement can be graded as continuous variables when a visual analogue scale was used or categorical variables when grading into two or more categories was provided
7 Trade names: Daflon, Detralex 7 trials - 1,692 patients
8 Reduction of pain
9 Reduction of heaviness
10 Reduction of feeling of swelling
11 Reduction of cramps
12 Reduction of paresthesia
13 Reduction of burning sensation
14 Tightness, Restless legs symptoms and fatigue: categorical variables Borderline statistical significance likely the result of a small sample size
15 Reduction of ankle circumference
16 Reduction of leg redness
17 Improvement of skin changes Skin changes were significantly improved with the use of Daflon compared with placebo
18 Trade names: Cyclo 3 Fort 10 trials patients
19 Reduction of pain
20 Reduction of heaviness 20
21 Reduction of feeling of swelling: continuous variable
22 Reduction of feeling of swelling: categorical variable
23 Reduction of fatigue
24 Reduction of cramps Parrado and Buzzi. Clin Drug Investig 1999
25 Reduction of paresthesia
26 Reduction of pruritus Pruritus severity was reduced with the use of Ruscus compared with placebo when assessed as a continuous variable (0.0±0.0 vs. 0.38±0.57, respectively, p<0.01)
27 Reduction of global symptoms : continuous variable
28 Reduction of global symptoms : categorical variable
29 Non significant changes Compared to placebo: Pruritus was non-significantly reduced with the use of Ruscus when assessed as a continuous variable Burning sensation was non-significantly reduced with the use of Ruscus when assessed as a continuous variable Cramps were non-significantly reduced with the use of Ruscus when assessed as a categorical variable (RR 0.63)
30 Reduction of ankle circumference
31 Reduction of foot/leg volume
32 Hydroxyethylrutosides Trade names: Relvene, Venoruton, Paroven 15 trials - 1,643 patients
33 Reduction of pain
34 Reduction of heaviness
35 Reduction of cramps
36 Other symptoms Feeling of swelling: OR 0.60, 95% CI Itching: OR 1.29; 95% CI Restless legs: results could not be pooled because of high statistical heterogeneity Paresthesia: results could not be pooled because of high statistical heterogeneity (I 2 =75%)
37 Horse chestnut seed extract (escin) Trade names: Venastat, Venaforce 2012, Issue 11. Art. No.: CD placebo controlled trials -1,292 patients
38 Reduction of pain
39 Reduction of feeling of swelling
40 Reduction of pruritus
41 Reduction of leg volume (ml)
42 Reduction of ankle circumference
43 Calcium Dobesilate Trade name: Doxytrex Angiology Volume 55, Number 2, trials patients
44 Night cramps discomfort paresthesia patient s opinion of symptom improvement
45 Leg volume pain heaviness heterogeneous variables
46 lower limb edema investigator s opinion of symptom improvement heterogeneous variables
47 Relative Effectiveness of VADs in CVD
48 Relative Effectiveness of VADs in CVD Symptom/Sign MPFF Ruscus Oxerutins HCSE Calcium + HMC Dobesilate + Vit C Pain A(4.2) A(5) B A(5.1) B(1) SMD Heaviness A(2.9) A(2.4) B(17) A(1) SMD Feeling of swelling A(3.1) A(4) SMD International Guidelines on CVD 2018 update Numbers in parentheses represent number needed to treat (NNT) SMD: standardized mean difference. A & B refer to levels of evidence. 48
49 Relative Effectiveness of VADs in CVD Symptom/Sign MPFF Ruscus Oxerutins HCSE Calcium + HMC Dobesilate + Vit C Leg fatigue NS B SMD Cramps B (4.8) B/C B SMD (-1.7) International Guidelines on CVD 2018 update Paresthesiae B/C(3.5) A (1.8) B(2) SMD Numbers in parentheses represent number needed to treat (NNT) SMD: standardized mean difference. A & B refer to levels of evidence. 49
50 Symptom/Sign MPFF Ruscus Oxerutins HCSE Calcium + HMC Dobesilate + Vit C Burning (NNT) B/C NS SMD Pruritus/Itching(NNT) B/C A(6.1) SMD Relative Effectiveness of VADs in CVD Functional discomfort/ discomfort (NNT) A (3.0) B(4) SMD International Guidelines on CVD 2018 update Numbers in parentheses represent number needed to treat (NNT) SMD: standardized mean difference. A & B refer to levels of evidence. 50
51 Relative Effectiveness of VADs in CVD Symptom/Sign MPFF Ruscus Oxerutins HCSE Calcium + HMC Dobesilate + Vit C Ankle circumf. B A NS A (4) SMD International Guidelines on CVD 2018 update Foot/leg Volume NS A NS A A SMD Numbers in parentheses represent number needed to treat (NNT) SMD: standardized mean difference. A & B refer to levels of evidence. 51
52 Relative Effectiveness of VADs in CVD Symptom/Sign MPFF Ruscus Oxerutins HCSE Calcium + HMC Dobesilate + Vit C Leg redness (NNT) B (3.6) SMD International Guidelines on CVD 2018 update Skin changes (NNT)A (1.6) Numbers in parentheses represent number needed to treat (NNT) SMD: standardized mean difference. A & B refer to levels of evidence. 52
53 Conclusions Most venoactive drugs are very effective in reducing a number of symptoms, including pain and heaviness, in patients with chronic venous insufficiency. Different clinical effects across the spectrum of defined symptoms.
54 Conclusions The NNT to improve venous symptoms with is generally small. This fact justifies reconsideration of the copay and reimbursement plans by the insurance companies.
55 Thank you!
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